NCT02024516

Brief Summary

The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 31, 2013

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 14, 2013

Last Update Submit

December 30, 2013

Conditions

Keywords

Type 2 diabetesPomegranateInflammationlipid profiles

Outcome Measures

Primary Outcomes (8)

  • Triglyceride change

    Baseline and after 4 weeks

  • Total Cholesterol change

    Baseline and after 4 weeks

  • HDL- Cholesterol change

    Baseline and after 4 weeks

  • LDL- Cholesterol change

    Baseline and after 4 weeks

  • hsCRP change

    Baseline and after 4 weeks

  • TNF- α change

    Baseline and after 4 weeks

  • IL-6 change

    Baseline and after 4 weeks

  • adiponectin change

    Baseline and after 4 weeks

Secondary Outcomes (3)

  • Fasting Blood Sugar change

    baseline and after 4 weeks

  • Blood Pressure change

    Baseline and after 4 weeks

  • Body Mass Index change

    baseline and after 4 weeks

Study Arms (1)

50 gr concentrated pomegranate juice

EXPERIMENTAL
Other: 50 gr concentrated pomegranate juice

Interventions

50 gr concentrated pomegranate juice

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • male or female 25 to 60 years old
  • having type 2 diabetes for at least 6 month

You may not qualify if:

  • pregnancy
  • lactation
  • cardiac disease
  • hepatic disease
  • respiratory disease
  • chronic renal diseases
  • acute or chronic inflammation
  • retinopathy
  • intake of antioxidant supplement
  • insulin therapy
  • sensitivity to concentrated pomegranate juice
  • change oral drug for controlling blood glucose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahvaz Jundishapoor University of Medical Sciences

Ahvāz, Khoozestan, Iran

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Inflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Maryam Zare, MS condidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritionist

Study Record Dates

First Submitted

December 14, 2013

First Posted

December 31, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations